{"id":5154,"date":"2020-01-08T17:04:00","date_gmt":"2020-01-08T17:04:00","guid":{"rendered":"https:\/\/medicalaffairs.travere.com\/?post_type=publication&#038;p=5154"},"modified":"2025-09-30T23:59:47","modified_gmt":"2025-09-30T23:59:47","slug":"phase-3-sparsentan-irbesartan-fsgs-duplex-study-design","status":"publish","type":"publication","link":"https:\/\/clleancode.top\/travere-redesign\/publications\/phase-3-sparsentan-irbesartan-fsgs-duplex-study-design\/","title":{"rendered":"Study Design of the Phase 3 Sparsentan Versus Irbesartan (DUPLEX) Study in Patients With Focal Segmental Glomerulosclerosis"},"content":{"rendered":"\n\n\n\n<section class=\"o-hero-section o-hero--banner o-hero--blue o-hero--cropped\">\n    <img decoding=\"async\" width=\"1920\" height=\"1080\" src=\"https:\/\/clleancode.top\/travere-redesign\/wp-content\/uploads\/2019\/10\/PROTECT-surrogate-efficacy-endpoints_header.png\" class=\"a-img a-img--right h-full\" alt=\"Hero Section Background Image\" 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   <div class=\"m-breadcrumb\">\n                <nav class=\"breadcrumbs\" aria-label=\"breadcrumb\"><span><span><a href=\"https:\/\/clleancode.top\/travere-redesign\/\">Home<\/a><\/span><\/span><\/nav>            <\/div>\n            <h1 class=\"a-heading a-heading--h1 h-white\">Study Design of the Phase 3 Sparsentan Versus Irbesartan (DUPLEX) Study in Patients With Focal Segmental Glomerulosclerosis<\/h1>                    <\/div>\n    <\/div>\n<\/section>\n\n\r\n\t<section style=\"margin-top:calc(-150px * var(--scale));\" class=\"section-container wp-block-grizzly-section-container\">\r\n\t\t\t\t<div class=\"container\">\r\n\t\t\t\n\n<div class=\"wp-block-group is-layout-constrained wp-container-core-group-is-layout-09ab29e6 wp-block-group-is-layout-constrained\">\n<div class=\"info-block info-block-publication search__container-publication search__container\">\n\t<div class=\"info-block-top\">\n\t\t<div>\n\t\t\t\t\t\t\t<div class=\"info-block-type\"><i class=\"icon2-journal\"><\/i> Journal article<\/div>\n\t\t\t\n\t\t\t\t\t\t\t<div class=\"info-block-type\">\n\t\t\t\t\t<i class=\"icon2-calendar\"><\/i> Published on January 8, 2020\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\n\t\t\t\t\t<div class=\"m-tags\">\n\t\t\t\t<p>Topics: <\/p>\n\t\t\t\t\t\t\t\t\t<span class=\"a-tag\">Nephrology<\/span>\n\t\t\t\t\t\t\t\t\t<span class=\"a-tag\">FSGS<\/span>\n\t\t\t\t\t\t\t<\/div>\n\t\t\t<\/div>\n\n\t<div class=\"info-block-bottom\">\n\t\t\t\t\t<div class=\"info-block-box\">\n\t\t\t\tContributors:<br \/><span>Komers R, Diva U, Inrig JK et al.<\/span>\n\t\t\t<\/div>\n\t\t\n\t\t<div class=\"info-block-box\">\n\t\t\t\t\t\t\tName of Journal:<br \/><span>Kidney International Reports<\/span><br \/><br \/><br \/>\n\t\t\t\n\t\t\t\t\t\t\t<a href=\"#\" data-url=\"https:\/\/linkinghub.elsevier.com\/retrieve\/pii\/S2468-0249(20)30003-6\" target=\"_blank\" rel=\"noopener noreferrer\" class=\"btn btn-outline leaving-modal-toggle btn-leaving\" aria-label=\"View Publication\">View Publication<\/a>\n\t\t\t\t\t<\/div>\n\n\t\t\t\t\t<div class=\"info-block-box info-block-doi\">\n\t\t\t\tDOI:<br \/><span>10.1016\/j.ekir.2019.12.017<\/span>\n\t\t\t<\/div>\n\t\t\n\t\t<div class=\"info-block-share\">Share:\n\t\t\t<span>\n\t\t\t\t\t<a href=\"https:\/\/twitter.com\/intent\/tweet?url=https%3A%2F%2Fclleancode.top%2Ftravere-redesign%2Fpublications%2Fphase-3-sparsentan-irbesartan-fsgs-duplex-study-design%2F&#038;text=Study+Design+of+the+Phase+3+Sparsentan+Versus+Irbesartan+%28DUPLEX%29+Study+in+Patients+With+Focal+Segmental+Glomerulosclerosis\" target=\"_blank\" rel=\"noopener noreferrer\" class=\"icon2-x\" aria-label=\"Share on Twitter\"><\/a> \n\t<a 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For more information, review the <a href=\"https:\/\/travere.com\/privacy\/\" target=\"_blank\">Travere privacy policies<\/a>.<\/span><\/label><\/span><\/span><\/span>\n  <\/div>\n  <div class=\"form-group text-right\">\n    <input class=\"wpcf7-form-control wpcf7-submit has-spinner btn\" id=\"request-submit\" type=\"submit\" value=\"Yes, continue\" \/>\n  <\/div>\n<\/div><div class=\"wpcf7-response-output\" aria-hidden=\"true\"><\/div>\n<\/form>\n<\/div>\n\t\t<\/div>\n\t<\/div>\n<\/div> <\/div>\n\n\t\t<\/div>\r\n\t<\/section>\r\n\t\n\n\r\n\t<section class=\"section-container wp-block-grizzly-section-container\">\r\n\t\t\t\t<div class=\"container\">\r\n\t\t\t\n\n<div class=\"wp-block-group is-layout-constrained wp-container-core-group-is-layout-09ab29e6 wp-block-group-is-layout-constrained\">\n<h2 class=\"wp-block-heading has-text-align-center has-heading-4-font-size\" id=\"h-summary\" style=\"margin-top:calc(60px * var(--scale));margin-bottom:calc(30px * var(--scale))\"><span class=\"fw-600\"><mark style=\"background-color:rgba(0, 0, 0, 0)\" class=\"has-inline-color has-teal-color\">Summary<\/mark><\/span><br><\/h2>\n\n\n\n<h3 class=\"wp-block-heading has-heading-5-font-size\" id=\"h-the-duplex-study-evaluated-estimated-glomerular-filtration-rate-egfr-and-fsgs-partial-remission-endpoint-fpre-in-sparsentan-versus-irbesartan-in-focal-segmental-glomerulosclerosis-fsgs-1\"><span class=\"fw-600\">The DUPLEX study evaluated estimated glomerular filtration rate (eGFR) and FSGS partial remission endpoint (FPRE) in sparsentan versus irbesartan in focal segmental glomerulosclerosis (FSGS)<sup>1<\/sup><\/span><\/h3>\n\n\n\n<div style=\"height:15px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<h4 class=\"wp-block-heading has-heading-5-font-size\" id=\"h-background\"><br><span class=\"fw-600\"><mark style=\"background-color:rgba(0, 0, 0, 0)\" class=\"has-inline-color has-ocean-blue-color\">Background<\/mark><\/span><\/h4>\n\n\n\n<div style=\"height:12px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<p>Focal segmental glomerulosclerosis (FSGS) can be classified as a primary, genetic, or secondary disorder:<\/p>\n\n\n\n<div style=\"height:12px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n<div class=\"wp-block-list-wrapper\">\n<ul class=\"wp-block-list\">\n<li><span class=\"fw-600\">Primary FSGS:<\/span> Has no identifiable cause but may be due to circulating permeability factors<sup>2<\/sup><\/li>\n\n\n\n<li><span class=\"fw-600\">Genetic FSGS:<\/span> May include mutations in genes encoding proteins required for normal podocyte structure and\/or function<sup>2,3<\/sup><\/li>\n\n\n\n<li><span class=\"fw-600\">Secondary FSGS:<\/span> May be caused by loss of renal mass, metabolic dysfunction, pre-existing diseases, infections, or drugs<sup>2<\/sup><\/li>\n<\/ul>\n<\/div>\n\n\n<div style=\"height:20px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<p>At least 50% of US patients with primary FSGS and<em> <\/em>nephrotic range proteinuria are resistant to treatment and will require renal replacement therapy in 5 to 10 years after diagnosis.<sup>1,4<\/sup><\/p>\n\n\n\n<div style=\"height:20px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<p>Although patients with responsive FSGS do have treatment options, the current treatment landscape is associated with serious side effects, highlighting the need for effective, safe, and well-tolerated treatments for FSGS.<sup>1,5<\/sup><\/p>\n\n\n\n<div style=\"height:20px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<p>Sparsentan is a first-in-class <a href=\"https:\/\/clleancode.top\/travere-redesign\/publications\/protective-mechanism-sparsentan-chronic-kidney-disease-models\/\" target=\"_blank\" rel=\"noreferrer noopener\"><span style=\"text-decoration: underline;\">dual endothelin-angiotensin receptor antagonist<\/span><\/a>.<sup>6 <\/sup>When compared to irbesartan in the <span style=\"text-decoration: underline;\"><a href=\"https:\/\/clleancode.top\/travere-redesign\/?post_type=publication&amp;p=5155\" target=\"_blank\" rel=\"noreferrer noopener\">DUET study<\/a><\/span>, sparsentan demonstrated a greater proteinuria reduction at 8&nbsp;weeks and a similar safety profile.<sup>7<\/sup><\/p>\n\n\n\n<div style=\"height:15px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<h5 class=\"wp-block-heading\" id=\"h-aim\"><br><span class=\"fw-600\"><mark style=\"background-color:rgba(0, 0, 0, 0)\" class=\"has-inline-color has-ocean-blue-color\">Aim<\/mark><\/span><\/h5>\n\n\n\n<div style=\"height:12px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<p>The DUPLEX study aimed to evaluate the long-term efficacy and safety of sparsentan versus irbesartan in FSGS.<sup>1<\/sup> This manuscript aims to describe the study design of DUPLEX.<sup>1<\/sup><\/p>\n\n\n\n<div style=\"height:20px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<p>Read more about the <span style=\"text-decoration: underline;\"><a href=\"https:\/\/clleancode.top\/travere-redesign\/publications\/sparsentan-versus-irbesartan-in-focal-segmental-glomerulosclerosis\/\" target=\"_blank\" rel=\"noreferrer noopener\">2-year data from DUPLEX<\/a><\/span>.<\/p>\n\n\n\n<div style=\"height:15px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<h5 class=\"wp-block-heading\" id=\"h-approach\"><br><span class=\"fw-600\"><mark style=\"background-color:rgba(0, 0, 0, 0)\" class=\"has-inline-color has-ocean-blue-color\">Approach<\/mark><\/span><\/h5>\n\n\n\n<div style=\"height:12px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<p><span class=\"fw-600\">Study overview and eligibility criteria<\/span><\/p>\n\n\n\n<div style=\"height:12px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<p>DUPLEX was a Phase 3, multicenter, double-blind, randomized trial that assessed sparsentan versus irbesartan in FSGS without known secondary causes.<sup>1<\/sup> Key inclusion criteria included<sup>1<\/sup>:<\/p>\n\n\n\n<div style=\"height:12px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n<div class=\"wp-block-list-wrapper\">\n<ul class=\"wp-block-list\">\n<li>Patients aged 8 to 75 years in the US and patients aged 18 to 75 outside the US<\/li>\n\n\n\n<li>Biopsy-confirmed FSGS or documentation of a genetic mutation in a podocyte protein associated with FSGS<\/li>\n\n\n\n<li>Urine protein-creatinine ratio (UPCR) of \u22651.5 g\/g<\/li>\n\n\n\n<li>Estimated glomerular filtration rate (eGFR) \u226530 mL\/min per 1.73 m<sup>2<\/sup><\/li>\n<\/ul>\n<\/div>\n\n\n<div style=\"height:40px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<p><span class=\"fw-600\">Study design<\/span><\/p>\n\n\n\n<div style=\"height:12px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<p>After successful screening, patients underwent a 2-week washout period from renin-angiotensin system inhibitors (RASi).<sup>1<\/sup> Patients were randomly assigned 1:1 to 800 mg of sparsentan or 300 mg of irbesartan.<sup>1<\/sup> The double-blind treatment period consisted of 108 weeks after which there was a 4-week no medication period.<sup>1<\/sup><\/p>\n\n\n\n<div style=\"height:20px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<p>Study visits occurred at Weeks 4, 6, 8, 12, and then every 12 weeks.<sup>1<\/sup><\/p>\n\n\n\n<div style=\"height:40px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<p><span class=\"fw-600\">Endpoints<\/span><\/p>\n\n\n\n<div style=\"height:12px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<p>The primary efficacy endpoint was the slope of eGFR measured from Week 6 to Week 108.<sup>1<\/sup><\/p>\n\n\n\n<div style=\"height:20px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<p>The surrogate efficacy endpoint was the proportion of patients at Week 36 who achieved a UPCR \u22641.5 g\/g and a &gt;40% reduction from baseline.<sup>1<\/sup> The proteinuric outcome for the DUPLEX study was FSGS partial remission endpoint (FPRE).<sup>8<\/sup><\/p>\n\n\n\n<div style=\"height:20px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<p>Secondary efficacy endpoints were a percent change in eGFR from<sup>1<\/sup>:<\/p>\n\n\n\n<div style=\"height:12px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n<div class=\"wp-block-list-wrapper\">\n<ul class=\"wp-block-list\">\n<li>Week 6 to Week 108<\/li>\n\n\n\n<li>Baseline to 4 weeks post-cessation of randomized treatment at Week 112<\/li>\n<\/ul>\n<\/div>\n\n\n<div style=\"height:20px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<p>Safety and tolerability of sparsentan were assessed by double-blind monitoring of several safety endpoints.<sup>1<\/sup><\/p>\n\n\n\n<div style=\"height:20px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<p><span class=\"fw-600\">Dive into the DUPLEX <a href=\"https:\/\/clleancode.top\/travere-redesign\/meetings-events\/era-congress-2025\/#duplex-low-proteinuria\" target=\"_blank\" rel=\"noreferrer noopener\"><em>post hoc <\/em>analyses<\/a> of proteinuria thresholds and the <a href=\"https:\/\/clleancode.top\/travere-redesign\/posters\/duplex-proteinuria-remission-fsgs\/\" target=\"_blank\" rel=\"noreferrer noopener\">effect on progression to kidney failure<\/a>.<\/span><\/p>\n\n\n\n<div style=\"height:15px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<h5 class=\"wp-block-heading\" id=\"h-key-takeaway\"><br><span class=\"fw-600\"><mark style=\"background-color:rgba(0, 0, 0, 0)\" class=\"has-inline-color has-ocean-blue-color\">Key takeaway<\/mark><\/span><\/h5>\n\n\n\n<div style=\"height:12px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<p>DUPLEX was a Phase 3, multicenter, double-blind, randomized trial that assessed sparsentan versus irbesartan in FSGS.<sup>1<\/sup> The primary and secondary endpoints evaluated eGFR at different intervals.<sup>1<\/sup> FPRE was the chosen surrogate efficacy endpoint.<sup>1<\/sup><\/p>\n\n\n\n<p><br><br><br><br><\/p>\n<\/div>\n\n\n\n<div class=\"wp-block-group is-layout-constrained wp-container-core-group-is-layout-09ab29e6 wp-block-group-is-layout-constrained\">\n<div class=\"newsletter\">\n\t<div class=\"newsletter-icon\">\n\t\t<span class=\"icon2-newsletter\"><\/span>\n\t<\/div>\n\t<div class=\"newsletter-text\">\n\t\t<p><strong>Sign up<\/strong> to receive scientific updates<br \/>\nfor healthcare professionals<br \/>\nfrom Travere Therapeutics.<\/p>\n\t<\/div>\n\t<div class=\"newsletter-form\">\n\t\t<script type=\"text\/javascript\">\n\/* <![CDATA[ *\/\nvar 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class=\"m-card__text\">\n\t\t\t\t<p class=\"a-heading a-heading--h4 h-ultra-dark-blue h-text-ellipsis h-w-medium\">\n\t\t\t\t\tSparsentan Clinical Trials in Glomerular Diseases: Defining Endpoints and a Path Forward\u00a0in Light of the Parasol Initiative\t\t\t\t<\/p>\n\t\t\t\t<p class=\"a-text a-text--m h-ultra-dark-blue\">\n\t\t\t\t\t \n\t\t\t\t\t\t\t\t\t\t2025\t\t\t\t<\/p>\n\t\t\t<\/div>\n\t\t\t\t\t\t\t<a href=\"#\" class=\"a-btn a-btn--secondary--blue btn-leaving leaving-modal-toggle\" data-url=\"https:\/\/www.tandfonline.com\/doi\/full\/10.1080\/23995270.2025.2461966\" aria-label=\"Read more: Sparsentan Clinical Trials in Glomerular Diseases: Defining Endpoints and a Path Forward\u00a0in Light of the Parasol Initiative\">\n\t\t\t\t\t<span>Read more<\/span>\n\t\t\t\t<\/a>\n\t\t\t\t\t<\/div>\n\t<\/article>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t<div class=\"swiper-slide\">\n\t\t\t\t\t\t\t\t<article class=\"m-card  \" aria-label=\"Publication card: Sparsentan versus Irbesartan in Focal Segmental Glomerulosclerosis\">\n\t\t<div class=\"m-card__top\">\n\t\t\t\t\t\t\t<a href=\"https:\/\/clleancode.top\/travere-redesign\/publications\/sparsentan-versus-irbesartan-in-focal-segmental-glomerulosclerosis\/\"  aria-label=\"View publication: Sparsentan versus Irbesartan in Focal Segmental Glomerulosclerosis\">\n\t\t\t\t\t\t\t\t\t\t\t\t<img decoding=\"async\" width=\"1920\" height=\"1080\" src=\"https:\/\/clleancode.top\/travere-redesign\/wp-content\/uploads\/2024\/08\/sparsentan-clinical-trial_header.png\" class=\"a-img\" alt=\"Sparsentan versus Irbesartan in Focal Segmental Glomerulosclerosis\" loading=\"lazy\" srcset=\"https:\/\/clleancode.top\/travere-redesign\/wp-content\/uploads\/2024\/08\/sparsentan-clinical-trial_header.png 1920w, https:\/\/clleancode.top\/travere-redesign\/wp-content\/uploads\/2024\/08\/sparsentan-clinical-trial_header-300x169.webp 300w, https:\/\/clleancode.top\/travere-redesign\/wp-content\/uploads\/2024\/08\/sparsentan-clinical-trial_header-1024x576.webp 1024w, https:\/\/clleancode.top\/travere-redesign\/wp-content\/uploads\/2024\/08\/sparsentan-clinical-trial_header-768x432.webp 768w, https:\/\/clleancode.top\/travere-redesign\/wp-content\/uploads\/2024\/08\/sparsentan-clinical-trial_header-1536x864.webp 1536w, https:\/\/clleancode.top\/travere-redesign\/wp-content\/uploads\/2024\/08\/sparsentan-clinical-trial_header-290x163.webp 290w\" sizes=\"auto, (max-width: 1920px) 100vw, 1920px\" \/>\t\t\t\t\t\t\t<\/a>\n\t\t\t<div class=\"m-card__info\">\n\t\t\t\t<div class=\"m-tags\">\n\t\t\t\t\t<span class=\"a-tag h-blue\">\n\t\t\t\t\t\t<i class=\"icon4 icon4-publication\"><\/i> Publication\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<span class=\"a-tag h-blue\">Nephrology<\/span><span class=\"a-tag h-blue\">FSGS<\/span>\t\t\t\t<\/div>\n\t\t\t<\/div>\n\t\t<\/div>\n\t\t<div class=\"m-card__bottom m-card--padding\">\n\t\t\t<div class=\"m-card__text\">\n\t\t\t\t<p class=\"a-heading a-heading--h4 h-ultra-dark-blue h-text-ellipsis h-w-medium\">\n\t\t\t\t\tSparsentan versus Irbesartan in Focal Segmental Glomerulosclerosis\t\t\t\t<\/p>\n\t\t\t\t<p class=\"a-text a-text--m h-ultra-dark-blue\">\n\t\t\t\t\t<em>New England Journal of Medicine<\/em> \n\t\t\t\t\t &#8211; \t\t\t\t\t2023\t\t\t\t<\/p>\n\t\t\t<\/div>\n\t\t\t\t\t\t\t<a href=\"https:\/\/clleancode.top\/travere-redesign\/publications\/sparsentan-versus-irbesartan-in-focal-segmental-glomerulosclerosis\/\" class=\"a-btn a-btn--secondary--blue\"  aria-label=\"Read more: Sparsentan versus Irbesartan in Focal Segmental Glomerulosclerosis\">\n\t\t\t\t\t<span>Read more<\/span>\n\t\t\t\t<\/a>\n\t\t\t\t\t<\/div>\n\t<\/article>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t<div class=\"swiper-slide\">\n\t\t\t\t\t\t\t\t<article class=\"m-card  \" aria-label=\"Publication card: Implications of Complete Proteinuria Remission at Any Time in Focal Segmental Glomerulosclerosis: Sparsentan DUET Trial\">\n\t\t<div class=\"m-card__top\">\n\t\t\t\t\t\t\t<a href=\"https:\/\/clleancode.top\/travere-redesign\/publications\/proteinuria-remission-fsgs-sparsentan-duet-trial\/\"  aria-label=\"View publication: Implications of Complete Proteinuria Remission at Any Time in Focal Segmental Glomerulosclerosis: Sparsentan DUET Trial\">\n\t\t\t\t\t\t\t\t\t\t\t\t<img decoding=\"async\" width=\"1920\" height=\"767\" src=\"https:\/\/clleancode.top\/travere-redesign\/wp-content\/uploads\/2023\/10\/pathology-of-igan_header.png\" class=\"a-img\" alt=\"Implications of Complete Proteinuria Remission at Any Time in Focal Segmental Glomerulosclerosis: Sparsentan DUET Trial\" loading=\"lazy\" srcset=\"https:\/\/clleancode.top\/travere-redesign\/wp-content\/uploads\/2023\/10\/pathology-of-igan_header.png 1920w, https:\/\/clleancode.top\/travere-redesign\/wp-content\/uploads\/2023\/10\/pathology-of-igan_header-300x120.webp 300w, 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class=\"a-heading a-heading--h4 h-ultra-dark-blue h-text-ellipsis h-w-medium\">\n\t\t\t\t\tImplications of Complete Proteinuria Remission at Any Time in Focal Segmental Glomerulosclerosis: Sparsentan DUET Trial\t\t\t\t<\/p>\n\t\t\t\t<p class=\"a-text a-text--m h-ultra-dark-blue\">\n\t\t\t\t\t<em>Kidney International Reports<\/em> \n\t\t\t\t\t &#8211; \t\t\t\t\t2023\t\t\t\t<\/p>\n\t\t\t<\/div>\n\t\t\t\t\t\t\t<a href=\"https:\/\/clleancode.top\/travere-redesign\/publications\/proteinuria-remission-fsgs-sparsentan-duet-trial\/\" class=\"a-btn a-btn--secondary--blue\"  aria-label=\"Read more: Implications of Complete Proteinuria Remission at Any Time in Focal Segmental Glomerulosclerosis: Sparsentan DUET Trial\">\n\t\t\t\t\t<span>Read more<\/span>\n\t\t\t\t<\/a>\n\t\t\t\t\t<\/div>\n\t<\/article>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"swiper-progressbar\"><\/div>\n\t\t\t<\/div>\n\t\t<\/div>\n\t\t<div class=\"publication-related-grid search-items__grid search__container\" id=\"search__container\" style=\"display: flex;\">\n\t\t\t\t<article class=\"m-card  m-card--no-image\" aria-label=\"Publication card: Sparsentan Clinical Trials in Glomerular Diseases: Defining Endpoints and a Path Forward\u00a0in Light of the Parasol Initiative\">\n\t\t<div class=\"m-card__top\">\n\t\t\t\t\t\t\t<a href=\"#\" class=\"btn-leaving leaving-modal-toggle\" data-url=\"https:\/\/www.tandfonline.com\/doi\/full\/10.1080\/23995270.2025.2461966\" aria-label=\"View publication: Sparsentan Clinical Trials in Glomerular Diseases: Defining Endpoints and a Path Forward\u00a0in Light of the Parasol Initiative\">\n\t\t\t\t\t\t\t\t\t\t<\/a>\n\t\t\t<div class=\"m-card__info\">\n\t\t\t\t<div class=\"m-tags\">\n\t\t\t\t\t<span class=\"a-tag h-blue\">\n\t\t\t\t\t\t<i class=\"icon4 icon4-publication\"><\/i> Publication\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<span class=\"a-tag h-blue\">Nephrology<\/span><span class=\"a-tag h-blue\">FSGS<\/span>\t\t\t\t<\/div>\n\t\t\t<\/div>\n\t\t<\/div>\n\t\t<div class=\"m-card__bottom m-card--padding\">\n\t\t\t<div class=\"m-card__text\">\n\t\t\t\t<p class=\"a-heading a-heading--h4 h-ultra-dark-blue h-text-ellipsis h-w-medium\">\n\t\t\t\t\tSparsentan Clinical Trials in Glomerular Diseases: Defining Endpoints and a Path Forward\u00a0in Light of the Parasol Initiative\t\t\t\t<\/p>\n\t\t\t\t<p class=\"a-text a-text--m h-ultra-dark-blue\">\n\t\t\t\t\t \n\t\t\t\t\t\t\t\t\t\t2025\t\t\t\t<\/p>\n\t\t\t<\/div>\n\t\t\t\t\t\t\t<a href=\"#\" class=\"a-btn a-btn--secondary--blue btn-leaving leaving-modal-toggle\" data-url=\"https:\/\/www.tandfonline.com\/doi\/full\/10.1080\/23995270.2025.2461966\" aria-label=\"Read more: Sparsentan Clinical Trials in Glomerular Diseases: Defining Endpoints and a Path Forward\u00a0in Light of the Parasol Initiative\">\n\t\t\t\t\t<span>Read more<\/span>\n\t\t\t\t<\/a>\n\t\t\t\t\t<\/div>\n\t<\/article>\n\t<article class=\"m-card  \" aria-label=\"Publication card: Sparsentan versus Irbesartan in Focal Segmental Glomerulosclerosis\">\n\t\t<div class=\"m-card__top\">\n\t\t\t\t\t\t\t<a href=\"https:\/\/clleancode.top\/travere-redesign\/publications\/sparsentan-versus-irbesartan-in-focal-segmental-glomerulosclerosis\/\"  aria-label=\"View publication: Sparsentan versus Irbesartan in Focal Segmental Glomerulosclerosis\">\n\t\t\t\t\t\t\t\t\t\t\t\t<img decoding=\"async\" width=\"1920\" height=\"1080\" src=\"https:\/\/clleancode.top\/travere-redesign\/wp-content\/uploads\/2024\/08\/sparsentan-clinical-trial_header.png\" class=\"a-img\" alt=\"Sparsentan versus Irbesartan in Focal Segmental Glomerulosclerosis\" loading=\"lazy\" srcset=\"https:\/\/clleancode.top\/travere-redesign\/wp-content\/uploads\/2024\/08\/sparsentan-clinical-trial_header.png 1920w, https:\/\/clleancode.top\/travere-redesign\/wp-content\/uploads\/2024\/08\/sparsentan-clinical-trial_header-300x169.webp 300w, https:\/\/clleancode.top\/travere-redesign\/wp-content\/uploads\/2024\/08\/sparsentan-clinical-trial_header-1024x576.webp 1024w, https:\/\/clleancode.top\/travere-redesign\/wp-content\/uploads\/2024\/08\/sparsentan-clinical-trial_header-768x432.webp 768w, https:\/\/clleancode.top\/travere-redesign\/wp-content\/uploads\/2024\/08\/sparsentan-clinical-trial_header-1536x864.webp 1536w, https:\/\/clleancode.top\/travere-redesign\/wp-content\/uploads\/2024\/08\/sparsentan-clinical-trial_header-290x163.webp 290w\" sizes=\"auto, (max-width: 1920px) 100vw, 1920px\" \/>\t\t\t\t\t\t\t<\/a>\n\t\t\t<div class=\"m-card__info\">\n\t\t\t\t<div class=\"m-tags\">\n\t\t\t\t\t<span class=\"a-tag h-blue\">\n\t\t\t\t\t\t<i class=\"icon4 icon4-publication\"><\/i> Publication\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<span class=\"a-tag h-blue\">Nephrology<\/span><span class=\"a-tag h-blue\">FSGS<\/span>\t\t\t\t<\/div>\n\t\t\t<\/div>\n\t\t<\/div>\n\t\t<div class=\"m-card__bottom m-card--padding\">\n\t\t\t<div class=\"m-card__text\">\n\t\t\t\t<p class=\"a-heading a-heading--h4 h-ultra-dark-blue h-text-ellipsis h-w-medium\">\n\t\t\t\t\tSparsentan versus Irbesartan in Focal Segmental Glomerulosclerosis\t\t\t\t<\/p>\n\t\t\t\t<p class=\"a-text a-text--m h-ultra-dark-blue\">\n\t\t\t\t\t<em>New England Journal of Medicine<\/em> \n\t\t\t\t\t &#8211; \t\t\t\t\t2023\t\t\t\t<\/p>\n\t\t\t<\/div>\n\t\t\t\t\t\t\t<a href=\"https:\/\/clleancode.top\/travere-redesign\/publications\/sparsentan-versus-irbesartan-in-focal-segmental-glomerulosclerosis\/\" class=\"a-btn a-btn--secondary--blue\"  aria-label=\"Read more: Sparsentan versus Irbesartan in Focal Segmental Glomerulosclerosis\">\n\t\t\t\t\t<span>Read more<\/span>\n\t\t\t\t<\/a>\n\t\t\t\t\t<\/div>\n\t<\/article>\n\t<article class=\"m-card  \" aria-label=\"Publication card: Implications of Complete Proteinuria Remission at Any Time in Focal Segmental Glomerulosclerosis: Sparsentan DUET Trial\">\n\t\t<div class=\"m-card__top\">\n\t\t\t\t\t\t\t<a href=\"https:\/\/clleancode.top\/travere-redesign\/publications\/proteinuria-remission-fsgs-sparsentan-duet-trial\/\"  aria-label=\"View publication: Implications of Complete Proteinuria Remission at Any Time in Focal Segmental Glomerulosclerosis: Sparsentan DUET Trial\">\n\t\t\t\t\t\t\t\t\t\t\t\t<img decoding=\"async\" width=\"1920\" height=\"767\" src=\"https:\/\/clleancode.top\/travere-redesign\/wp-content\/uploads\/2023\/10\/pathology-of-igan_header.png\" class=\"a-img\" alt=\"Implications of Complete Proteinuria Remission at Any Time in Focal Segmental Glomerulosclerosis: Sparsentan DUET Trial\" loading=\"lazy\" srcset=\"https:\/\/clleancode.top\/travere-redesign\/wp-content\/uploads\/2023\/10\/pathology-of-igan_header.png 1920w, https:\/\/clleancode.top\/travere-redesign\/wp-content\/uploads\/2023\/10\/pathology-of-igan_header-300x120.webp 300w, https:\/\/clleancode.top\/travere-redesign\/wp-content\/uploads\/2023\/10\/pathology-of-igan_header-1024x409.webp 1024w, https:\/\/clleancode.top\/travere-redesign\/wp-content\/uploads\/2023\/10\/pathology-of-igan_header-768x307.webp 768w, https:\/\/clleancode.top\/travere-redesign\/wp-content\/uploads\/2023\/10\/pathology-of-igan_header-1536x614.webp 1536w, https:\/\/clleancode.top\/travere-redesign\/wp-content\/uploads\/2023\/10\/pathology-of-igan_header-290x116.webp 290w\" sizes=\"auto, (max-width: 1920px) 100vw, 1920px\" \/>\t\t\t\t\t\t\t<\/a>\n\t\t\t<div class=\"m-card__info\">\n\t\t\t\t<div class=\"m-tags\">\n\t\t\t\t\t<span class=\"a-tag h-blue\">\n\t\t\t\t\t\t<i class=\"icon4 icon4-publication\"><\/i> Publication\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<span class=\"a-tag h-blue\">Nephrology<\/span><span class=\"a-tag h-blue\">FSGS<\/span>\t\t\t\t<\/div>\n\t\t\t<\/div>\n\t\t<\/div>\n\t\t<div class=\"m-card__bottom m-card--padding\">\n\t\t\t<div class=\"m-card__text\">\n\t\t\t\t<p class=\"a-heading a-heading--h4 h-ultra-dark-blue h-text-ellipsis h-w-medium\">\n\t\t\t\t\tImplications of Complete Proteinuria Remission at Any Time in Focal Segmental Glomerulosclerosis: Sparsentan DUET Trial\t\t\t\t<\/p>\n\t\t\t\t<p class=\"a-text a-text--m h-ultra-dark-blue\">\n\t\t\t\t\t<em>Kidney International Reports<\/em> \n\t\t\t\t\t &#8211; \t\t\t\t\t2023\t\t\t\t<\/p>\n\t\t\t<\/div>\n\t\t\t\t\t\t\t<a href=\"https:\/\/clleancode.top\/travere-redesign\/publications\/proteinuria-remission-fsgs-sparsentan-duet-trial\/\" class=\"a-btn a-btn--secondary--blue\"  aria-label=\"Read more: Implications of Complete Proteinuria Remission at Any Time in Focal Segmental Glomerulosclerosis: Sparsentan DUET Trial\">\n\t\t\t\t\t<span>Read more<\/span>\n\t\t\t\t<\/a>\n\t\t\t\t\t<\/div>\n\t<\/article>\n\t\t<\/div>\n\t\t<div class=\"publication-related-btn\">\n\t\t\t<a href=\"https:\/\/clleancode.top\/travere-redesign\/publications\/\" class=\"a-btn a-btn--primary\" aria-label=\"See more\">See more<\/a>\n\t\t<\/div>\n\t<\/div>\n\n\n\n<div style=\"height:40px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<h5 class=\"wp-block-heading\" id=\"h-footnotes\" style=\"padding-bottom:calc(30px * var(--scale))\"><mark style=\"background-color:rgba(0, 0, 0, 0)\" class=\"has-inline-color has-ocean-blue-color\"><span class=\"fw-600\">Footnotes<\/span><\/mark><\/h5>\n\n\n\n<p class=\"has-small-font-size\" style=\"margin-bottom:calc(30px * var(--scale))\">Sparsentan is not FDA-approved for the treatment of FSGS.<\/p>\n\n\n\n<p class=\"has-small-font-size\" style=\"margin-bottom:calc(30px * var(--scale))\">eGFR, estimated glomerular filtration rate; FPRE, FSGS partial remission endpoint; FSGS, focal segmental glomerulosclerosis; RASi, renin-angiotensin system inhibitor; UPCR, urine protein-creatinine ratio.<\/p>\n\n\n<div class=\"wp-block-list-wrapper\">\n<ol class=\"wp-block-list\">\n<li class=\"has-small-font-size\">Komers R et al. <em>Kidney Int Rep<\/em>. 2020;5(4):494-502.<\/li>\n\n\n\n<li class=\"has-small-font-size\">D\u2019Agati VD et al. <em>N Engl J Med<\/em>. 2011;365:2398-2411.<\/li>\n\n\n\n<li class=\"has-small-font-size\">Sadowski CE et al. <em>J Am Soc Nephrol<\/em>. 2015;26:1279-1289.<\/li>\n\n\n\n<li class=\"has-small-font-size\">Korbet SM. <em>J Am Soc Nephrol. <\/em>2012;23:1769-1776.<\/li>\n\n\n\n<li class=\"has-small-font-size\">Kidney Disease: Improving Global Outcomes (KDIGO) Glomerular Diseases Work Group. KDIGO 2021 clinical practice guideline for the management of glomerular diseases. <em>Kidney Int<\/em>. 2021;100:S1-S276.<\/li>\n\n\n\n<li class=\"has-small-font-size\">Komers R and Plotkin H. <em>Am J Physiol Regul Integr Comp Physiol<\/em>. 2016;310(10):R877-884.<\/li>\n\n\n\n<li class=\"has-small-font-size\">Trachtman H et al. <em>J Am Soc Nephrol<\/em>. 2018;29(11):2745-2754.<\/li>\n\n\n\n<li class=\"has-small-font-size\">Troost JP et al. <em>Clin J Am Soc Nephrol<\/em>. 2018;13:414-421.<\/li>\n<\/ol>\n<\/div>\n\n\n<p class=\"has-text-align-right\" style=\"margin-top:calc(30px * var(--scale));margin-bottom:calc(300px * var(--scale))\">MA-SP-24-0110 | June 2025<\/p>\n<\/div>\n\n\t\t<\/div>\r\n\t<\/section>\r\n\t","protected":false},"featured_media":4590,"template":"","meta":{"inline_featured_image":false,"header_bg_color":"transparent","header_fixed":true,"post_description":"","post_download_link":"","journal_link":"","pdf_file_link":""},"product":[78],"therapeutic_area":[97],"disease_area":[186],"study_registry":[187],"study_type":[176],"resource_type":[177,180],"class_list":["post-5154","publication","type-publication","status-publish","has-post-thumbnail","hentry","product-spa","therapeutic_area-neph","disease_area-fsgs","study_registry-duplex","study_type-clinical","resource_type-publication","resource_type-summary"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v24.9 (Yoast SEO v27.4) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>DUPLEX Study Design: Sparsentan Versus Irbesartan in FSGS | Travere Medical Affairs<\/title>\n<meta name=\"description\" content=\"Learn more about the DUPLEX study design, which evaluated the efficacy and safety of sparsentan versus irbesartan in FSGS. 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